Systems Engineer - Mechanical Engineer
Systems Engineer - Mechanical Engineer
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Job Description
Working for Micro Systems Engineering Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices our continuing success is based on our companys corevalues - innovation quality reliability integrity teamwork and undisputed expertise - thus enabling usto inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers scientists and professionals to share in our mission.
Please join us as:
Systems Engineer - Mechanical Engineer
We are seeking a Systems Engineer - Mechanical Engineer to join our R&D team. This role places you at the technical center of development of complex implantable medical devices focusing on the design of mechanical aspects of active implantable devices and their accessories. The role involves collaboration across multidisciplinary teams including mechanical electrical and software teams. This role involves contributions from prototype phases through verification and validation all the way to post-market product support.
Key Responsibilities
System Design & Integration
- Lead mechanical design and system integration of implantable and accessory devices.
- Define and manage subsystem requirements and interfaces.
- Collaborate with electrical manufacturing and human factors engineering teams to ensure cohesive system design.
Prototyping & Development
- Support rapid prototyping including 3D printing and bench testing.
- Apply iterative development methods to refine mechanical components.
- Verification Validation & Testing
- Develop and execute test plans to ensure compliance with performance safety and regulatory requirements.
- Support and lead risk management activities including FMEA fault tree analysis and root cause investigations.
- Regulatory & Standards Compliance
- Ensure design activities comply with relevant standards (e.g. IEC 60601 ISO 14971 FDA QSR EU MDR).
- Document system behavior and design decisions in line with regulatory expectations.
Post-Market Engineering
- Provide technical support for released products including root cause analysis and implementation of design improvements.
- Analyze field and product performance data to drive continuous improvement.
Your Profile
Education
- Bachelors Degree or higher in a technical field such as Mechanical Engineering Biomedical Engineering or a related discipline.
- Work Experience
- Industry Experience: Minimum 5 years of experience in mechanical or systems engineering and preferably:
- Experience with neurostimulation or other similar active implantable devices.
- Exposure to manufacturing processes for implantable devices.
- Understanding of human factors and usability engineering in medical systems.
Desired Technical Skills & Competencies:
- Proficient in mechanical design and CAD (Solidworks or similar)
- Experience with mechanical prototyping and 3D printing.
- Knowledge of verification and validation practices (Design & Process V&V).
- Understanding of biocompatibility testing and materials for implantable
- Proficiency in at least one data processing scripting and plotting software (e.g. VS Code Matlab python)
- Experience writing technical documents and working drawings for manufacturing
- Experience working with regulatory standards such as ISO 14708 IEC 60601 FDA 21 CFR 820.11 MDR and ISO 14971.
- Experience working in requirements management tools
- Project Management Skills: Proven ability to organize prioritize and execute multiple projects in a fast-paced detail-oriented environment.
- Communication & Teamwork: Strong interpersonal and communication skills with the ability to effectively collaborate across teams and present complex ideas clearly.
- Ability to prioritize effectively and work on concurrent projects.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills including technical report writing skills.
Location
- Lake Oswego OR this is a hybrid position.
Location: Lake Oswego(0001)
Working hours: Full-time
MSEI Lake OswegoOregon (US-OR)USA
Job ID: 60995
Micro Systems Engineering Inc. is an equal opportunity accordance with applicable law the company prohibits discrimination based on race color religion creed gender pregnancy or related medical conditions age national origin or ancestry physical or mental disability sexual orientation genetic information uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee
Employment Type
Full-Time
